Critically analyse what makes for sufficient disclosure in the description of a patentable invention, focusing in particular on Biogen v Medeva and subsequent related cases. Is this a case of one rule for simple products and another for complex product-by-process claims?

This means, that in the light of the above mentioned undue claim width doctrine and with regard to immature fields in historical sense the reasoning that the specification must make up for sufficient disclosure that enables the invention to be performed to the full extent of the monopoly claimed, aims for a limitation of patentability for the sake of not unduly stifling industrial and technological development in this field[12]. Thus, it becomes clear that when Lord Hoffman held that the legal principle is that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified[13], it severed the sake of not over-monopolizing a young science field. This analysis is affirmed by the Lord Hoffman’s conclusion that the claim wording which aims for a monopoly on any recombinant method of making the antigens is not justified as a claim because the essential features relevant for technical contribution as disclosed by the specification did not enable a person skilled in the art for the ‘any recombinant of’ scope of invention[14].

The HoL’s ratio decidendi in Biogen as analyzed above has been purporting a new principle of insufficiency that does not differentiate between simple products or classes of products comprised by wide processing methods, i.e. flowerpots and DNA sequences.

Along with partially application of Biogen insufficiency principle by the courts, the unitary rule to apply this rationale to all kind of claimed inventions and their disclosure in the specification raised criticism. This lead to a renunciation thereof in Lundbeck[15], whereas Lord Hoffmann, plagued of his own dicta, concluded that the Biogen insufficiency is to be limited to product-by-process claims and therefore his learned friend Kitchen J. erred in equating the relevant technical contribution to the method rather than to the product, because the Biogen insufficiency does not apply to simple product claims in which the technical contribution of the invention is the product itself[16], even when only one method to create it is disclosed in the patent specification[17]. Moreover, Lord Hoffmann clarified that with regard to the Biogen insufficiency, the respective statutory provisions and EPC statues as mentioned above do not lead inevitably to the conclusion that simple product claims must also support all methods of creating the product[18].

In conclusion, the marriage of ‘sufficiency disclosure’ concept to the invention itself as defined in the claims under the clarification in Lundbeck was confirmed in Conor Medsystems[19]. Hereby, it was established that when determining the inventive step, it is only necessary to consider the invention as defined by the claims, and not in the disclosure in the patent specification[20], and therefore, there is still room for debate in this issue, when the scope of invention is to be construed.

[1] In other words, in the age of industrialization or in times of a technology leap of industrial or otherwise applicable development, such as nowadays biotech, the proposes of disclosure is, besides to limit the scope of monopoly right granted to the inventor by the claims of the patent, to facilitate technology transfer or diffusion of knowledge. Reference is made to David J. Brennan, “The Evolution of English Patent Claims as Property Definers” (2005) 4 Intellectual Property

Quarterly pp 362-363

[2] Liardet v Johnson Unreported 1778, per Lord Mansfield in ibid supra note 1 p 370 In the late 18th century, where Lord Mansfield held that the meaning of the specification is that others may be taught to do a thing for which the patent is granted and if a specification is false the patent has to be voided

[3] Patents Act 1977 ss 14(3), 14(5) and 72(1)(c)

[4] ibid c.37 and s 72(1)(c)

[5] Asahi Kasei Kogyo KK's Application [1991] R.P.C. 485

[6] Valensi v British Radio Corp [1972] F.S.R. 273; [1973] R.P.C. 337 at 377 and Mentor Corp v Hollister Inc [1993] R.P.C. 7 in Tim Leung, 'Generics (UK) Ltd v H Lundbeck A/S: In search of optimal patent protection: Biogen insufficiency and the chequered history of product claims' (2010) 32 4 E.I.P.R. p 4

[7] The Mullard Radio Valve Co Ltd v Philco Radio and Television Corporation of Great Britain (1936) 53 R.P.C. 323 per Lord Alness at 349

[8] Biogen v. Medeva [1997] RPC1

[9] As a result of recommendation of the Parker Committee which convened in 1916, the prevention of exploitation of the patent laws by foreigners was repeatedly emphasized, and therefore it was concluded that the object of granting patents for new inventions is to benefit the trade or industry of the United Kingdom. This resulted in the establishment of s.38A that was introduced to address specific concerns that chemical product patents held by German companies (particularly in the dyestuffs industry) were unacceptably inhibiting the development of British industry by preventing technology transfer and innovation. The s.38A of the Patents Act of 1919 provided that: In the case of inventions relating to substances prepared or produced by chemical processes or intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the special methods or processes of manufacture described and claimed or by their obvious chemical equivalents. This provision was abandoned with the superseding Patents Acts 1949 since at this time the British domestic industry was capable of innovating in competition with foreign industry; it was disadvantaged by strong patent rights relative to more advanced foreign entities. Tim Leung, 'Generics (UK) Ltd v H Lundbeck A/S: In search of optimal patent protection: Biogen insufficiency and the chequered history of product claims' (2010) 32 4 E.I.P.R. p 3

[10] Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46

[11] Biogen v Medeva [1997] RPC 1 at 47-9 per Lord Hoffmann; contra Molynlcke AB v Proctor & Gamble Ltd [1994] R.P.C. 49; Chiron Corp v Organon Teknika Ltd (No.3) [1994] F.S.R. 202.

[12] Tim Leung, 'Generics (UK) Ltd v H Lundbeck A/S: In search of optimal patent protection: Biogen insufficiency and the chequered history of product claims' (2010) 32 4 E.I.P.R. pp 2, 5

[13] Case T-409/91 Exxon/Fuel Oils [1994] E.P.O.R. 149; [1994] OJ EPO 653 at [3.3] which regard to Biogen v Medeva [1997] RPC 1 in Tim Leung, 'Generics (UK) Ltd v H Lundbeck A/S: In search of optimal patent protection: Biogen insufficiency and the chequered history of product claims' (2010) 32 4 E.I.P.R. p 5

[14] Biogen v. Medeva [1997]  RPC 1 paras 51, 52

[15] Generics (UK) Limited and others v H Lundbeck A/S [2009] UKHL 12

[16] Generics (UK) Ltd v Lundbeck A/S [2008] EWCA Civ 311; [2008] R.P.C. 19 at [40].

[17] Generics (UK) Ltd v Lundbeck A/S [2008] EWCA Civ 311; [2008]  R.P.C. 19 at [35].

[18] Eddy Ventose, 'The House of Lords Clarifies “Biogen Insufficiency', (2009) 6 3 SCRIPTed <http://www.law.ed.ac.uk/ahrc/script-ed/vol6-3/ventose.asp>accessed on 21 September 2013 p

[19] Conor Medsystems Inc v Angiotech Pharmaceuticals Inc

[20] Sebastian Moore and Duncan  Ribbons, “The Court of Appeal Clarifies the Law on Sufficiency” (2009) Journal of Intellectual Property Law & Practice p 352.